Medication is, of course, intended to help people. So, we need to know the ingredients, such as the API, are safe to use. No matter where an API is produced, it has to meet the safety and quality criteria of the country where end users are located. That means drugs sold in the EU need to meet the strict safety and quality standards of the European Medicines Agency, and those sold in the US need to meet the regulations issued by the U.S. Food and Drug Administration (FDA).
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Companies in the entire API supply chain get inspected by their local government. Foreign governments instances could also inspect them, and third-party companies do audits of each other companies.
When everything is up to code, companies are given a certain certificate, such as GMP or a written confirmation, so other professionals in the industry know that that specific company complies with the industry standards without them having to inspect or audit themselves. When the inspection fails, the companies will be issued a warning, and pharmaceutical buyers won&#;t be able to buy there until the issues are resolved and the company is re-inspected.
Not only the factory or production facility is inspected, but laboratories also analyze every batch of produced API; depending on the situation, it is even possible that one specific batch is analyzed multiple times: For example, by the company that produced it, by a 3rd party laboratory, by the trader who buys it, and by the hospital that will use it.
Also, every pharmaceutical company has an entire team dedicated to quality assurance and quality control. This team can consist of pharmacists, chemists, biologists and other trained and qualified personnel. You could say that the first team, quality assurance, ensures everything is fine before the production process starts, while quality control ensures everything is performed according to plan.
Nonproprietary names: USAN/INN
While the number of available prescription or over-the-counter drugs (OTC) under different names increases daily, the situation differs in the case of APIs. Considering how expensive the steps to introducing a new drug to the market are, there isn&#;t a great number of new APIs being introduced. An API is sold under only one name: the nonproprietary name.
To avoid confusion in this market, which potentially would have dangerous consequences, WHO, in cooperation with national drug safety agencies worldwide, came up with a list of non-proprietary names back in . The organization revises the list regularly, and you can send them a request for new International Nonproprietary Names (INN).
So, everywhere in the world, Ramipril is sold as Ramipril, and that API can&#;t be bought under any other name. Drug manufacturers can sell their drugs under any name they want, but they must put the API name right under the brand name.
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About API
API (Active Pharmaceutical Ingredient) means the active ingredient which is contained in medicine. For example, an active ingredient to relieve pain is included in a painkiller. This is called API. A small amount of the active ingredient has an effect, so only a tiny part of the active ingredient is contained in medicine. You will find the name and amount of the active ingredient contained in the medicine on the package of OTC (over-the-counter) drugs.
How APIs are made
API and raw material are often confused due to the similar usage of the two terms. What is the difference? Raw material refers to chemical compounds that are used as a base to make an API. We purchase the raw materials from raw material or chemical product manufacturers both in Japan and internationally. When using the raw materials, as an API manufacturer we produce API in the large reactor in our plant. The API is not made by only one reaction from the raw materials but rather it becomes an API via several chemical compounds. The chemical compound which is in the process of becoming an API from a raw material is called an intermediate. Among the APIs we produce, there is an API which passes through over ten kinds of intermediates in a process when it changes from being a raw material into an API. After this long manufacturing process, it is purified until it reaches a very high degree of purity and finally becomes an API.
Who makes APIs
First of all, as an API manufacturer we think of how to make a chemical compound which becomes an API in the laboratory. We also have to consider the degree of concentration and which temperature allows a high quality of API to be manufactured efficiently. In order to find answers to these questions, our staff in the development department set about conducting a series of experiments. Once they have decided how to make the compound, our staff in the production department manufacture a high quantity of APIs using the large reactors in our plant. Our quality control staff then conducts analyses in the testing laboratory to examine whether the API manufactured is ultrapure. After testing, our quality assurance staff confirms that everything has been performed correctly in accordance with GMP from manufacturing of API to quality testing. As you can see, a considerable number of staff is involved in the production phase until an API is finally manufactured.
From API to patient
We manufacture APIs and drug manufacturers make medicines from APIs. In addition to APIs, a variety of pharmaceutical excipients are contained in the medicine. Drug manufacturers make medicines by mixing APIs and pharmaceutical excipients. This is how an API becomes a medicine. It is delivered to hospitals and pharmacies until it reaches the patient. If an API is not ultrapure, a medicine cannot meet the strict quality criteria so the quality of an API plays a very important role.
For more information, please visit active pharmaceutical ingredient classification.